NCT04410965已完成4 期
Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 Weeks
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- PK exposure: Cmax
研究概览
简要总结
Primary Objective:
Evaluate the relationship between ABCG2 mutation (rs2231142) and teriflunomide exposure, during 6-month treatment with teriflunomide 14 mg
Secondary Objective:
Characterize the safety (AEs, such as ALT enhancement, hair thinning, diarrhea, nausea, etc.) during 6-month treatment with teriflunomide
详细描述
Study duration per participant is approximately 28 weeks including a 24-week treatment period
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
teriflunomide
Experimental
daily oral administration of teriflunomide 14 mg for 24 weeks
干预措施: TERIFLUNOMIDE (Drug)
结局指标
主要结局
PK exposure: Cmax
时间窗: From Week 8 to Week 24
PK exposure Cmax will be estimated by PopPK analysis.
PK exposure: AUCtau
时间窗: From Week 8 to Week 24
PK exposure AUCtau will be estimated by PopPK analysis
次要结局
- Participants with Serious Adverse Events and Adverse Events(Screening to Week 24)
研究者
研究点 (1)
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